The decision to administer chemotherapy following tumor resection usually depends on an oncologist's assessment of the presence of residual disease. While computed tomography, magnetic resonance imaging, or tissue/sentinel lymph node biopsy analysis can detect some level of residual disease (up to a resolution of ~2 mm or ~190,000 cells), the presence of circulating tumor cells (CTCs) is believed to correlate most sensitively with cancer progression. Reliable measurement of CTCs, however, remains difficult, because CTCs are extremely low in abundance at early stages of metastasis or immediately after tumor resection surgery. To advance cancer diagnosis to the next stage, IVDiagnostics seeks to develop a "drug-and-device" combination product "IVFLOW" for detecting single CTC in peripheral blood. Following the labeling of CTCs by systemic administration of a tumor-specific reagent, a fiber-topic probe will be put against a surface vessel for enumerating cancer cells when they flow through the vessel. It can be argued that increasing of the blood sampling volume enables the enumeration of rare CTCs statistically significant. Therefore, this test can reduce the uncertainty of rare CTC counting in a blood-drawn test. To achieve the above goal, IVDiagnostics project team will break this project into three specific aims shown below: 1) Design and develop a prototype imaging device for IVFLOW system, 2) Test and optimize the prototype device using a microfluidic system, and 3) Test this device using an animal model. With launching IVFLOW system into the market, IVDiagnostics anticipates this product will dramatically increase patients'survival rates and significantly reduce medical costs for cancer management. PUBLIC HEALTH RELEVANCE: In Phase I of this SBIR project, IVDiagnostics will develop IVFLOW, a laser-guided device that allows a patient's peripheral blood to be analyzed in a quick, easy and inexpensive fashion following systemic administration of a fluorescent, tumor-specific probe. This test provides a more sensitive tool for oncologists for early detection of metastatic diseases. Thus, this test potentially increases patients'survival rates and reduces medical costs for cancer management.